Label: MENTHOL AND ZINC OXIDE ointment

  • NDC Code(s): 10135-701-04
  • Packager: Marlex Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Active Ingredients

    Menthol 0.44%

    Zinc Oxide 20.625%

  • Purpose

    External Analgesic

    Skin Protectant

  • Uses

    A moisture barrier that prevents & helps heal skin irritations from:

    • Urine
    • Diarrhea
    • Perspiration
    • Fistula drainage
    • Feeding tube site leakage
    • Wound drainage (peri-wound skin)
    • Minor burns
    • Cuts
    • Scrapes
    • Itching
  • Warnings

    For external use only

    • Not for deep or puncture wounds
    • Avoid contact with eyes

    Stop use and ask doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Cleans with mild skin cleanser
    • Pat dry or allow to air dry
    • Apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.
  • Other Information

    • Store at room temperature 20°- 25° C (68°F-77°F)
  • Inactive Ingredients

    Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin, Isopropyl Alcohol, Hard Paraffin

  • Package label


    Menthol and Zinc Oxide Ointment

    701-04

  • INGREDIENTS AND APPEARANCE
    MENTHOL AND ZINC OXIDE 
    menthol and zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.625 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    THYMOL (UNII: 3J50XA376E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOL (UNII: 339NCG44TV)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-701-04113 g in 1 TUBE; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01505/01/2021
    Labeler - Marlex Pharmaceuticals, Inc. (782540215)
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